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Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model (SAAGE)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Students with Autism Accessing General Education
Enhanced Services As Usual
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children subjects:

  • Are enrolled in school grades kindergarten through 5th
  • Have an IEP educational classification of Autism, confirmed by the Autism Diagnostic Observation Schedule, Second Edition, and DSM-5 checklist
  • No planned changes in school placement or core team members during the school year of participation

Adult subjects (teachers, para educators):

  • Instructional personnel who currently support a participating child with ASD at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist)
  • Letter from instructional personnel's district or school indicating agreement to take part in the research project

Exclusion Criteria:

Children subjects • Diagnosis of (1) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis; 2) profound vision or hearing loss; or (3) motor disabilities such as cerebral palsy (these multiple disabilities would prevent standard implementation of the intervention protocol).

Adult subjects

• Instructional personnel whose written consent was not obtained

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Enhanced Services As Usual

Arm Description

Students with Autism Accessing General Education (SAAGE). Teaching staff work with a study team coach to identify areas of concern for individual students, create goals and implement a modular behavioral intervention using an active teaching/feedback loop model.

Teaching staff access in-service training sessions hosted by study team and are provided with print materials from which the modules for the active intervention were created.

Outcomes

Primary Outcome Measures

Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale
The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting.

Secondary Outcome Measures

Mean change in social communication and interaction as rated by child's teacher using the 30 item Social Skills Subscale of the Social Skills Improvement System
The Social Skills Improvement System, Social Skills Subscale is a 30 item measure of social communication and interaction using a 4 point Likert scale to rate the frequency of behaviors and a 3 point Likert scale to the the importance of each item.
Mean change in restricted and repetitive behavior as measured by the Children's Yale-Brown Obsessive-Compulsive Scales - PDD
The Children's Yale-Brown Obsessive-Compulsive Scales - PDD is a modified version of the Children's Yale-Brown Obsessive-Compulsive Scales which is adapted for use with children with ASD. It is a semi structured clinician rated scale designed to rate the current severity of repetitive behavior. Each item is scored on a 5 point scale from 0 to 4 with 4 being most symptomatic.
Change in teacher-nominated target behaviors
Teacher Nominated Target Behaviors
Change in on-task behavior during instruction
Academic Engaged Time
School-related adaptive functioning
Adaptive Behavior Assessment System, Self-Direction Scale
Social skills and behavior regulation
Social Skills Improvement System
Class placement
IEP review

Full Information

First Posted
June 6, 2018
Last Updated
November 14, 2018
Sponsor
University of Rochester
Collaborators
May Institute, University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03573128
Brief Title
Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
Acronym
SAAGE
Official Title
Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
May Institute, University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study personnel will use evidence based behavioral skills training procedures to coach educators to implement modules designed to increase the quality of educational services and access to inclusive settings in elementary school for students with Autism Spectrum Disorder.
Detailed Description
This project brings together the expertise of investigators at three centers to develop and conduct a pilot test of a new comprehensive intervention to increase the quality of educational services and access to inclusive settings for students with autism spectrum disorder (ASD) in elementary school (kindergarten through 5th grade). The intervention model, Students with Autism Accessing General Education (SAAGE), integrates evidence-based strategies to teach skills to students with ASD in schools, best practices derived from this literature by the project investigators, a recent guidebook written by the principal investigator, and research on collaboration with community providers such as school teams to implement interventions efficaciously and sustainably. SAAGE begins with strategies to help a school form a cohesive team to oversee implementation of the model in the school. For each student, SAAGE uses a modular approach for identifying goals for a student, selecting appropriate teaching strategies, and systematically monitoring progress and trouble-shooting. The modules center on core and associated features of ASD. Study personnel will use well established behavioral skills training procedures to coach educators to implement the modules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Students with Autism Accessing General Education (SAAGE). Teaching staff work with a study team coach to identify areas of concern for individual students, create goals and implement a modular behavioral intervention using an active teaching/feedback loop model.
Arm Title
Enhanced Services As Usual
Arm Type
Active Comparator
Arm Description
Teaching staff access in-service training sessions hosted by study team and are provided with print materials from which the modules for the active intervention were created.
Intervention Type
Behavioral
Intervention Name(s)
Students with Autism Accessing General Education
Intervention Description
With study team coach support, teacher implemented modules addressing student behavioral/academic goals.
Intervention Type
Other
Intervention Name(s)
Enhanced Services As Usual
Intervention Description
Teaching staff access in-service presentations and print materials with no active study team coaching.
Primary Outcome Measure Information:
Title
Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale
Description
The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting.
Time Frame
baseline to end of school year (approx. 9 months)
Secondary Outcome Measure Information:
Title
Mean change in social communication and interaction as rated by child's teacher using the 30 item Social Skills Subscale of the Social Skills Improvement System
Description
The Social Skills Improvement System, Social Skills Subscale is a 30 item measure of social communication and interaction using a 4 point Likert scale to rate the frequency of behaviors and a 3 point Likert scale to the the importance of each item.
Time Frame
baseline to end of school year (approx. 9 months)
Title
Mean change in restricted and repetitive behavior as measured by the Children's Yale-Brown Obsessive-Compulsive Scales - PDD
Description
The Children's Yale-Brown Obsessive-Compulsive Scales - PDD is a modified version of the Children's Yale-Brown Obsessive-Compulsive Scales which is adapted for use with children with ASD. It is a semi structured clinician rated scale designed to rate the current severity of repetitive behavior. Each item is scored on a 5 point scale from 0 to 4 with 4 being most symptomatic.
Time Frame
baseline to end of school year (approx. 9 months)
Title
Change in teacher-nominated target behaviors
Description
Teacher Nominated Target Behaviors
Time Frame
baseline to end of school year (approx. 9 months)
Title
Change in on-task behavior during instruction
Description
Academic Engaged Time
Time Frame
baseline to end of school year (approx. 9 months)
Title
School-related adaptive functioning
Description
Adaptive Behavior Assessment System, Self-Direction Scale
Time Frame
baseline to end of school year (approx. 9 months)
Title
Social skills and behavior regulation
Description
Social Skills Improvement System
Time Frame
baseline to end of school year (approx. 9 months)
Title
Class placement
Description
IEP review
Time Frame
baseline to end of school year (approx. 9 months)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children subjects: Are enrolled in school grades kindergarten through 5th Have an IEP educational classification of Autism, confirmed by the Autism Diagnostic Observation Schedule, Second Edition, and DSM-5 checklist No planned changes in school placement or core team members during the school year of participation Adult subjects (teachers, para educators): Instructional personnel who currently support a participating child with ASD at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist) Letter from instructional personnel's district or school indicating agreement to take part in the research project Exclusion Criteria: Children subjects • Diagnosis of (1) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis; 2) profound vision or hearing loss; or (3) motor disabilities such as cerebral palsy (these multiple disabilities would prevent standard implementation of the intervention protocol). Adult subjects • Instructional personnel whose written consent was not obtained
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristram H Smith, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model

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